Kornimate/medical-research-clean huggingface dataset:
liom non-invasive continuous glucose monitor "clinical demo" (nicgm)

Conditions: Type 1 Diabetes; Type2diabetes

Summary: this is a single-centre, multiple cohort, open study.

the study will include 5 cohorts. after each cohort, optimisation of the spiden clinical demo 2.0 system and machine learning models may be pursued before the next cohort is started. trial participants with type 1 or type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * male or female trial participant with clinically diagnosed type 1 or type 2 diabetes for at least 1 year. * age between 18 and 65 years, both inclusive. * treated with insulin and/or oral antidiabetic drugs (oads; type 2 only), multiple dosing insulin therapy (mdi), continuous subcutaneous insulin infusion (csii) or a hybrid closed loop system. exclusion criteria: * known or suspected hypersensitivity to any of the components of the liom clinical demo 2.0. * trial participant with any injury, infection, atypical skin condition (e.g., hyperkeratosis, hyperpigmentation) of or tattoo on the wrists. * presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.

Keywords: hyperglycemia diabetes mellitus transcutaneous spectral fingerprint non-invasive
new generation igra in immunocompromised individuals

Conditions: Monitoring, Immunologic; Active Tuberculosis; Tuberculosis in Solid Organ Transplant Recipients; Tuberculosis in Marrow Transplant Recipients; Tuberculosis in Rheumatoid Arthritis; Tuberculosis in Chronic Renal Failure; Tuberculosis in HIV-infected Individuals

Summary: evaluation of a new elisa based interferon-gamma release assay (quantiferon tb plus in-tube test) in immunocompromized patients

this study is designed to evaluate the performance of a new elisa based quantiferon-tb plus in-tube test to identify m. tuberculosis specific immune responses as evidence of latent infection with m. tuberculosis in immunosuppressed populations. both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with m. tuberculosis. in addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.

Eligibility criteria:
inclusion criteria: * individuals as specified for the study population * written informed consent exclusion criteria: * \<18 years of age
efficacy and safety of comp360 psilocybin therapy in anorexia nervosa: a proof-of-concept study

Conditions: Anorexia Nervosa

Summary: efficacy and safety of comp360 psilocybin therapy in anorexia nervosa: a proof-of-concept study

this study aims to explore the efficacy and safety of comp360 25 mg as compared to comp360 1 mg (control condition) administered with psychological support in participants with anorexia nervosa

Eligibility criteria:
inclusion criteria: 1. any sex and aged 18 years or above at screening. 2. meeting criteria for an either restrictive or binge-purging type, according to the dsm-5, based on medical records, clinical assessment, bmi, and documented completion of mini 7.0.2 and ede at screening. 3. have successfully discontinued all prohibited medications for a period of at least two weeks prior to baseline. for fluoxetine (prozac), immediate cessation at screening period visit 1a followed by at least four weeks of washout will be required prior to baseline. 4. has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with an. 5. bmi ≥15 kg/m2 and ≤20 kg/m2. for participants with a bmi \ 18.5 kg/m2 at screening, approval from the medical monitor will be required. any participant with a bmi \>18.5 kg/m2 must meet all of the criteria for an except that, despite significant weight loss, the individual's weight is within or above the normal range. 6. being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ecg, and medical history. 7. have at least one documented prior attempt at treatment in the past 3 years. exclusion criteria: 1. prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (mini 7.0.2). 2. prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment. 3. borderline personality disorder as demonstrated by medical history, the mini plus - bpd and clinical judgment. 4. significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the c-ssrs within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview. 5. current (within last year) alcohol or substance use disorder as informed by the dsm-5 assessed via the mini 7.0.2, and urine toxicology at screening. 6. other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin. 7. exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, lsd, or peyote within the past year.
psoriatic arthritis research collaborative: biologic sub-study

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is an inflammatory arthritis with substantial variation in clinical features. we propose a multicenter collaborative approach to better understand the phenotypes and current management of psa in the united states.the central goal of this proposal is to obtain the data necessary to design a pragmatic trial in psa.

psoriatic arthritis (psa) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. the management of a patient with psa is extremely challenging due to the high degree of phenotypic heterogeneity. the ultimate goal of this proposal is to prepare pragmatic trials in psa trials that will encompass all relevant subgroups of patients. the aims of this study specifically focus on responses to biologic therapy among patients with psa and determining the optimal set of outcome measures for psa trials.

Eligibility criteria:
inclusion criteria: * age 18-89 * active psa (at least one swollen joint or enthesitis) -meet caspar criteria (table 2) (103) -initiation of tnfi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (at the time of the submission, tnfi biosimilars have been approved by the fda but are not available on the us market. once available, patients starting tnfi biosimilars will similarly be eligible for participation. patients may have been on the medication in the past but must have had greater than 2 months off the medication.patients may be taking other traditional dmards. a washout period is not required.) exclusion criteria: * unable to give informed consent * out of the age range * switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms. * patients with only active psa
community clinic test of youth anxiety treatment

Conditions: Anxiety; Depression

Summary: structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. such findings have led to proposals that the empirically supported treatments be used to improve outcomes of conventional clinic treatment, which some research suggests may not be very effective. but can these lab-tested treatments actually work in service-oriented clinics with referred youth? available evidence cannot tell us, because the therapists, conditions, and clientele in the laboratory efficacy tests tend to differ so markedly from those of clinical practice. to assess the clinical potential of efficacy-tested treatments, we need effectiveness research that tests these treatments in the crucible of clinical practice. to help begin this process, the proposed research focuses on a specific treatment program for a specific cluster of disorders: kendall's (1994) cognitive-behavioral "coping cat" program for child and adolescent anxiety disorders. the program has shown unusually positive effects across a series of clinical trials in the u.s. and australia, but it has never been tested in real-world clinical conditions. the proposed study will test the effectiveness of the treatment with clinic-referred youth, treated in community clinics, with the treatment carried out by clinic staff therapists. some 128 youth, aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly assigned to receive either the usual treatment in the clinic, or the kendall program, carried out by clinic staff who have been trained to proficiency. therapists for the two treatment conditions will also be chosen randomly, from a pool of volunteers. outcome assessment at immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many outcomes. it is hypothesized that outcomes for youths treated using the cognitive-behavioral treatment will be superior to those treated using usual care.


Eligibility criteria:
inclusion criteria: * primary dsm-iv anxiety or depressive disorder exclusion criteria: * pervasive developmental disorder * psychotic disorder * mental retardation

Keywords: cognitive behavioral therapy anxiety treatment depression treatment child treatment usual care
hyperthermia in fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: this study will examine the effectiveness of water-filtered whole-body hyperthermia during an outpatient setting in patients with fibromyalgia. the duration of the study is about 3 weeks with two treatment units per week and a passive period (follow-up measurement) of 24 weeks after the outpatient setting.

a total of about 40 participants over 18 years of age are sought, who will be divided into two groups of equal size after inclusion in the study. all participants will receive the same amount of water-filtered whole-body hyperthermia within the outpatient setting. one group receives the gentle form of gkht, the other group receives the classic, mild ghkt. all abnormalities are documented by the responsible therapists, doctors and nurses. changes in the area of pain and functional limitations as well as the intake of required medication are also recorded. before the start and after the completion of the studies, within the clinical stay, blood parameters were collected. in order to determine the secondary effectiveness of different questionnaire values are also collected. these are also documented after week 12 and after week 24, by means of telephone enquiries.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of fibromyalgia (fsq) * pain vas \>= 4,0 * signed declaration of consent exclusion criteria: * participation in other clinical studies * contraindications for hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women) * acute and / or feverish microbial infections * patients with severe somatic, rheumatic concomitant endocrine or neurological diseases, in particular neurological diseases associated with cognitive disorders, severe liver or kidney and cardiac diseases * patients who are permanently treated with opioids, cannabis, immunosuppressive drugs (e.g. corticoids, immunosuppressants) or alpha/beta-a(nta)gonists due to a disease from the group described above * patients with pain due to a serious psychiatric illness (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) and serious systemic or neurological disorders

Keywords: hyperthermia fibromyalgia syndrome pain
lower extremity functional training (lift) on gross motor function and gait in children with spastic cp

Conditions: Cerebral Palsy

Summary: cerebral palsy is a developmental disorder caused by damage to the brain before, during or after birth. spastic cerebral palsy is one of the most common types of cerebral palsy. it affects about 80% of cerebral palsy. spastic cp is characterized by increased muscle tone, jerky movements, joint stiffness, and muscle tightness. spastic cerebral primarily affects strength, coordination, and balance resulting in gait difficulties and affecting gross motor functioning. these abnormalities affect the very basic activities of daily life (adls). even if the child is able to walk the motor skills are usually disturbed which are very important to improve and maintain gross motor functioning. physical therapy plays a vital role in overcoming these issues.

in the previous studies the effects of lift on the trunk and core has been studies however, the data on the effects on the gross motor skills are very less. in addition to that the effects of lower extremity functional training on the gait have also been limited to a few studies only. the past studies were of very short time period due to which the proper effects of lift on the gait and gross motor skills were not very well understood.

Eligibility criteria:
inclusion criteria: * patients who are not able to stand * age between 7 to 16 years * patients living near the designated center exclusion criteria: * patients with comorbidities * patients with cognitive impairment * patients who are not able to follow commands * patients with a history of falls

Keywords: cerebral palsy. gait training, motor learning, functional training, balance, hemiplegic gait.
thiocolchicoside injection and capsule in treatment of acute low back pain

Conditions: Low Back Pain

Summary: to assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.


Eligibility criteria:
inclusion criteria: * diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale. * presence of lumbar muscular contracture exclusion criteria: * acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins * patients with psychiatric or mental diseases, or unable to follow the requests of the protocol * renal failure (serum creatinine \> 160 µmol/l or \> 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin \> 2 upper normal limit). * positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion. * severe heart failure. * myopathy / myasthenia. * patients treated during two days prior to inclusion with steroidal agents. * known or suspected hypersensitivity to thiocolchicoside. * known or suspected hypersensitivity to nonsteroidal anti-inflammatory drugs * history of active peptic ulcer or gastro intestinal bleeding. * history of nonsteroidal anti-inflammatory drugs induced allergic asthma. * concomitant treatment with 2-agonists (i.e. clonidine). * pregnant or breast feeding women. * females of child bearing potential, not taking adequate contraception. * patients with history of alcohol, drugs or narcotics abuse. * previous inclusion in this study or in another study in the past 6 months.
early recognition of hypoxia in pediatric patient sedation

Conditions: Desaturation of Blood

Summary: early recognition of hypoxia through monitoring in sedation practices in pediatric patients

in pediatric magnetic resonance imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. it was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.

Eligibility criteria:
inclusion criteria: * patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia exclusion criteria: * patients over the age of 18, * those who do not speak turkish, * presence of deformities in the nose and forehead, * those with nail polish and henna on their nails

Keywords: hypoxia desaturation microstream capnography pulseoxymeter
prospective longitudinal evaluation of ai-ecg in a newly diagnosed heart failure

Conditions: Heart Failure

Summary: background: heart failure (hf) is a condition in which the heart can no longer adequately pump blood around the body. the number of patients diagnosed with hf is increasing, consuming 4% of the nhs budget, and deadlier than most cancers. most patients suffer from hf with reduced ejection fraction (hfref), where adequate treatment can improve quality of life and survival. less than 50% of patients receive gold standard nhs guided medication and less than 20% receive appropriate monitoring (via echocardiography surveillance). this study looks at the use of a 'smart stethoscope' (eko duo), a stethoscope that uses information collected from the heart in the form of electrical (ecg) and sounds (phonocardiogram, pcg) waveforms, to predict the pumping function of the heart via artificial intelligence (ai-ecg). aims: by using the smart stethoscope, this study evaluates whether the use of an easy-to-use home self-monitoring programme can: * provide a solution for the current poor compliance of nhs echocardiogram surveillance programmes for people with newly diagnosed hf * provide real-time assessment of heart function in response to medication changes * improve the health economic and health outcomes of hf in the nhs methods: 80 participants with newly diagnosed hfref, due to pre-existing heart disease and non-heart related causes, will be identified by the clinical team at imperial college nhs trust and obtain consent for the research team to approach them. all consented participants will receive a smart stethoscope and instructions for twice-weekly, 15-second self-examination for 3-months. participants will also be invited for an additional echocardiogram at 6 weeks post-diagnosis, in addition to the routine, standard of care nhs echocardiogram surveillance for hf.


Eligibility criteria:
inclusion criteria: * age 18 years or above * able to give informed consent * newly diagnosed with hfref (i.e., lvef below 40%) assessed by a consultant cardiologist within the past two weeks. exclusion criteria: * any chest wound, skin pathology or other feature that would prohibit routine eko duo examination. * participants who have been diagnosed with hf previously

Keywords: heart failure remote monitoring machine learning
dietary interventions on glycocalyx dimensions in south asian patients with diabetic nephropathy.

Conditions: Diabetic Nephropathy Type 2; Albuminuria; Type2 Diabetes Mellitus; Glucose Metabolism Disorders; Microalbuminuria; Diabetic Nephropathies; Diabetic Complications Renal; Diabetes Mellitus; Kidney Diseases; South Asian

Summary: evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in south asian type 2 diabetic patients with albuminuria.


Eligibility criteria:
inclusion criteria: 1. south asian patient with diabetes mellitus type 2. 2. female or male, aged between 18 and 75 years. 3. body mass index ≥18.5. 4. ckd-epi \>45 ml/min/1.73m² . 5. proven microalbuminuria defined as albumin/creatinine ratio ≥0.3 and \<30 mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine collection) in the last twelve months. 6. systolic blood pressure ≤ 180 mmhg. 7. treatment with hypoglycemic drugs: metformin, sulphonylureas and/or insulin. 8. subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure. 9. patients must be able to adhere to the study visit schedule and protocol requirements. 10. if female and of child-bearing age, patients must be non-pregnant, non-breastfeeding, and use adequate contraception. 4.3 exclusion exclusion criteria: 1. any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol. 2. non-diabetic renal disease e.g. known polycystic kidney disease. 3. use of lmw heparin and/or immunosuppressive drugs. 4. significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided. 5. signs of active infection or autoimmune disease, requiring systemic treatment. 6. a psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 7. malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). 8. use of any other investigational drug. 9. patient has enrolled another clinical trial within last 4 weeks.
to investigate efficacy and safety of a single injection of gensci094 for ovarian stimulation using daily recombinant fsh as reference

Conditions: Infertility

Summary: to investigate the efficacy and safety of a single injection of gensci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant fsh (recfsh) as a reference. the primary hypothesis is that a single injection of gensci094 is non-inferior to daily treatment with recfsh in initiating multi-follicular growth.


Eligibility criteria:
inclusion criteria: * females of couples with an indication for controlled ovarian stimulation (cos) and in-vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi); * \>=20 and \<40 years of age at the time of signing informed consent; * body weight \>=50 kg and body mass index (bmi) \>=18 and \<=28 kg/m\^2; * amh\ =1.1μg/l fsh\<10 iu/l * willing and able to sign informed consent. exclusion criteria: * history of ovarian hyper-response or ovarian hyperstimulation syndrome (ohss); * history of/or current polycystic ovary syndrome (pcos); * more than 20 basal antral follicles \<11 mm (both ovaries combined) as measured on ultrasound scan (uss) in the early follicular phase (menstrual cycle day 2-4); * presence of unilateral or bilateral hydrosalphinx (visible on uss); * presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>4 cm; * more than three unsuccessful ivf cycles since the last established ongoing pregnancy (if applicable); * history of non- or low ovarian response to fsh/ human menopausal gonadotropin (hmg) treatment; * history of recurrent miscarriage (3 or more, even when unexplained); * any clinically relevant abnormal laboratory value based on a sample taken during the screening phase; * contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); * recent history of/or current epilepsy, human immunodeficiency virus (hiv) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease; * use of hormonal preparations within 1 month prior to randomization; * hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol; * administration of investigational drugs within three months prior to signing informed consent.